Pricing and Reimbursement Regulations in TurkeyAny role for HTA?

Dr Rabia KahveciGeneral Directorate of Pharmaceuticals and

Pharmacies

Ministry of Health, Turkey

2004-2009

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Pharmaceutical Regulations in Turkey

• Ministry of Health, General Directorate of Pharmaceuticals and Pharmacies– Licencing and Pricing (external reference)– Pharmacovigilance, drug safety, consumer relations,

pharmacies…– Department of Pharmacoeconomics

• Social Security Institution– Reimbursement Decisions

• Reimbursement Commission• Medical and Economical Evaluation committee

– Implementation Guidelines

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Health care expenditures

First 8 months of 2009;

• 23.778.542.000 TL total (10.808.428.000 euros)

• 10.342.669.000 TL pharmaceuticals (4.701.213.000 euros, 43,5% of total)

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• Pharmaceutical expenditures in first 8 months of 2009 compared to first 8 months of 2008– nominal increase as 21,41%

– Real increase as 12,43%

• As volume (3% increase)• first 8 months of 2008: 983.169.883

• first 8 months of 2009: 1.013.309.863

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Nominal Changes in SSI health care expenditures, 2002-2009, (first 8 months), (%)

2003 2004 2005 2006 2007 2008

August 2008-2009

Total 36,56 23,83 4,7 30,54 15,69 20,95 11,67Pharmaceu

ticals 30,74 17,98 7,64 16,01 10,45 16,42 21,41

2003 2004 2005 2006 2007 2008

August 2008-2009

Total 8,99 11,97 -4,94 18,12 6,37 9,51 3,41Pharmace

uticals 4,34 6,67 -2,27 4,98 1,55 5,42 12,43

Real Changes in SSI health care expenditures, 2002-2009, (first 8 months), (%)

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Milestones in Pricing and Reimbursement of pharmaceuticals

• 2004 April..reference pricing• 2004..Reimbursement Commission under Ministry of

Finance• 2005..Regulations on licencing of pharmaceuticals• 2005 ..Positive list for reimbursement• 2006..Pharmaceutical expenditure tracking system

under SSI and MEDULA initiated• 2007..new health budget law adopted• 2008..mandatory pharmacoeconomic analysis in

industry submissions for coverage• 2008..General health insurance• 2009..Drug Track and Trace System• 2009 Sept..Change in Pricing Legislation• 2009 Sept.. Changes in Reimbursement Rules

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In the first three years of the Health Care Transformation Program although health expenditures rose rapidly, increases in both total and public spending on health care seem to have remained affordable because economic growth in Turkey was also rapid….

Increase in access, decrease in pharmaceutical prices, decrease in taxes, increase in GDP…

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1984 Legislation for Pharmaceutical Pricing•System based on costs•Company’s declaration•No discounting

14th February 2004 (revised in 2007) Reference Pricing (5-10 EU member states, lowest exfactory

price is reference, generics get 80% of original)Transparent and Objective CriteriaPrice Evaluation CommissionReimbursement Commission

An annual saving of 900 million USD

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Pharmaceutical Before (2004)Legislation

After (2004) Legislation

%of Decrease

PERMAX 14.570.000 2.900.000 80,10 %ZOCOR 46.098.000 10.920.000 76,31 %PROZAC 5 ML 23.244.000 10.010.000 56,94 %LOSEC 22.408.000 12.910.000 42,39 %DIAMICRON 16.244.000 9.600.000 40,90 %NORVASC 36.168.000 21.860.000 39,56 %TİLCOTİL 10.559.000 6.430.000 39,10 %VİAGRA 63.617.000 55.870.000 12,18 %ASPİRİN 395.000 390.000 1,27 %

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Reference Pricing14th February 2004

MoH

Reimbursement Commission14th February 2004

MoF

Protocol on Public Reimbursement

14th December 20044-11% discount for public

Equivalance Reimbursement Band %30May 2005

Insurances United December 2005 Positive list

January 2006

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Protocol on Public Reimbursement, 2004 Reference countries: Portugal, Spain, France, Italy and Greece

100% of Min Ref

Original Price

80% of Original

Generic Price

11% Public discount

Later than 6 years

11% Public discount

Earlier than 6 years

4% Public discount

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Equivalance Reimbursement Band,2005

• Equivalance defined as: same active substance, same dose, same route..

• A 10 mg 20 tb…30 TL

• B 10 mg 20 tb…35 TL

• C 10 mg 20 tb…37 TL

• D 10 mg 20 tb…41 TL

Band:30 plus 30x30%

39 TL

D is 2 TL above band

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Positive list January 2006

SSI Law PassedMay 2006

Revision of Positive list June 2006

Reimbursement Commission redefined under SSI

June 2007

Equivalance Band narrowed to 22 %

May 2006

Mandatory Pharmacoeconomical Analysis in Submission

May-Oct 2008

Public discount 11 % for allSeptember 2008

Equivalance Band narrowed to 15 %

June 2009 14

Equivalance Reimbursement Band,2006, 2009

• A 10 mg 20 tb…30 TL

• B 10 mg 20 tb…35 TL

• C 10 mg 20 tb…37 TL

• D 10 mg 20 tb…41 TL

Band:30 plus 30x22%

36,6 TL

C and D is above band

Band:30 plus 30x15%

34,5 TL

B, C and D is above band

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September 2009 Regulations!!!

• 18th Sept 2009/revised in 2nd Dec 2009 : New Pricing Legislation ..

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Pricing regulations, 2009

100% of Min Ref

Original Price

80% of Original

Generic Price

11% Public discount

Generics in the market

Org price 66%

11% public discount

11% Public discount

66%

No generic in the market

23%

EXCEPTIONSProducts less than 10 TL

Blood productsEnteral feedingCritical drug list

RadiopharmaceuticalsOTCs

Expected saving 3 billion TL

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Current Problems (1)

• Economical crisis..big issue

• Increasing pharmaceutical expenditures still a problem

• Reference countries do not reflect the lowest prices in Europe

• Reimbursement Prices might still be higher than many wealthier countries

• Need for redefining equivalency and further step for internal reference pricing

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BiphosphonatesAlendronic acid vs Risedronic acidReimbursement Price

15 % band

25,55 TL Andante Tb 70 mg 4 tb

28,43 TL Bonacton Tb 70 mg 4 tb

28,43 TL Bonemax Tb 70 mg 4 tb

28,64 TL Fosamax Tb 70 mg 4 tb

28,43 TL Osalen Tb 70 mg 4 tb

28,43 TL Osteomax Tb 70 mg 4 tb

24,91 TL Vegabon Tb 70 mg 4 tb

Reimbursement Price

15 % band

50,49 TL Actonel 35 mg 4 tb

40,26 TL Arilex 35 mg 4 tb

330,5 TL/year

555,6 TL/year

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Current Problems (2) • Fixed copayment and a long list of no copayment

• No flexibility in reimbursement prices– No risk-sharing

– No internal reference pricing

– Fixed copayments

• Still no value at this stage

• No HTA in pricing

• Need for further improvement in reimbursement criteria based on cost-effectiveness and definite role for HTA here!

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ThanksTHANK YOU

rabiakahveci@gmail.com21